GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Metoclopramide Tablets USP 5mg
B) Metoclopramide Tablets USP 10mg
B) Metoclopramide Tablets USP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Metoclopramide Tablets USP 5mg
Each uncoated tablet contains:
Metoclopramide HCl USP
Equivalent to anhydrous Metoclopramide HCl…………5mg
Excipients…………………………………………………………………q.s.
Colour: Ferric Oxide Yellow
B) Metoclopramide Tablets USP 10mg
Each uncoated Tablet contains:
Metoclopramide HCl USP
Equivalent to anhydrous Metoclopramide HCl…………10mg
Excipients…………………………………………………………………q.s.
Colour: Indigo Carmine
Each uncoated tablet contains:
Metoclopramide HCl USP
Equivalent to anhydrous Metoclopramide HCl…………5mg
Excipients…………………………………………………………………q.s.
Colour: Ferric Oxide Yellow
B) Metoclopramide Tablets USP 10mg
Each uncoated Tablet contains:
Metoclopramide HCl USP
Equivalent to anhydrous Metoclopramide HCl…………10mg
Excipients…………………………………………………………………q.s.
Colour: Indigo Carmine
THERAPEUTIC INDICATIONS:
Metoclopramide is used to treat certain conditions of the stomach and intestines. Metoclopramide is used as a short-term treatment (4 to 12 weeks) for ongoing heartburn when the usual medicines do not work well enough. It is used mostly for heartburn that occurs after a meal or during the daytime. Treating ongoing heartburn can decrease the damage done by stomach acid to the swallowing tube (esophagus) and help healing. Metoclopramide is also used by diabetic patients who have poor emptying of their stomachs (gastroparesis). Treating gastroparesis can decrease symptoms of nausea, vomiting, and stomach/abdominal fullness. Metoclopramide works by blocking a natural substance (dopamine).
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from Light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Protect from Light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Metoclopramide Tablets USP 5mg Technical Specification:
| Product Name: | Metoclopramide Tablets USP |
| Brand Name: | Generic |
| Strength: | 5mg, 10mg |
| Dosage Form: | Tablets (Uncoated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Gastroenterological |
| Indication: | Metoclopramide is used to treat the symptoms of slow stomach emptying (gastroparesis) in patients with diabetes. It works by increasing the movements or contractions of the stomach and intestines. It relieves symptoms such as nausea, vomiting, heartburn, a feeling of fullness after meals, and loss of appetite. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Metoclopramide Tablets USP 5mg
- Metoclopramide Tablets USP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Metoclopramide Tablets USP 5mg
Each uncoated tablet contains:
Metoclopramide HCl USP
Equivalent to anhydrous Metoclopramide HCl…………5mg
Excipients…………………………………………………..q.s.
Colour: Ferric Oxide Yellow - Metoclopramide Tablets USP 10mg
Each uncoated Tablet contains:
Metoclopramide HCl USP
Equivalent to anhydrous Metoclopramide HCl…………10mg
Excipients…………………………………………………..q.s.
Colour: Indigo Carmine
THERAPEUTIC INDICATIONS:
Metoclopramide is used to treat certain conditions of the stomach and intestines. Metoclopramide is used as a short-term treatment (4 to 12 weeks) for ongoing heartburn when the usual medicines do not work well enough. It is used mostly for heartburn that occurs after a meal or during the daytime. Treating ongoing heartburn can decrease the damage done by stomach acid to the swallowing tube (esophagus) and help healing. Metoclopramide is also used by diabetic patients who have poor emptying of their stomachs (gastroparesis). Treating gastroparesis can decrease symptoms of nausea, vomiting, and stomach/abdominal fullness. Metoclopramide works by blocking a natural substance (dopamine).
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from Light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
